Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.

Launched by IMPERIAL COLLEGE HEALTHCARE NHS TRUST · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help women who experience vaginal bleeding after menopause and may need testing for endometrial cancer (cancer of the womb lining). The trial aims to see if using an ultrasound to guide a small biopsy device, called a Pipelle®, can improve the chances of getting a good tissue sample during an outpatient procedure. This is important because sometimes the biopsy does not provide enough tissue, leading to the need for more invasive tests. The trial will also look at whether this method is less painful and helps patients receive treatment faster.

Women who have post-menopausal bleeding and meet specific criteria, such as having a certain thickness of the womb lining, may be eligible to participate. The study will involve 92 participants who will be randomly assigned to either the ultrasound-guided method or the traditional method without ultrasound. The trial will take place over three years at Queen Charlotte's and Chelsea Hospital. If you decide to participate, you’ll be part of a study that could help improve the experience and outcomes for future patients in similar situations.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • All patients with post-menopausal bleeding who require an endometrial biopsy.
• Further details:
• • Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.
• • There is no upper age limit, however all patients must be 18 or above.
• Strict ultrasound criteria will be followed:
• • Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.
• • Smooth, homogenous endometrium with a clearly defined border.
• Exclusion Criteria:
• • Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).
• • Suspicion of non-benign myometrial pathology.
• • History of endometrial cancer or endometrial hyperplasia.
• • History of cervical cancer.
• • Virgo intacta.
• • Inability to tolerate vaginal examination.
• • Inability to consent.
• • The denial or withdrawal of informed written consent.